Label: GLIZIGEN SKIN PROTECTANT- glycerin spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 28, 2017

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  • ACTIVE INGREDIENT

    Glycerin 0.5%................Skin Protectant

    Bottle

  • ASK DOCTOR

    • Stop use and ask a doctor if rash occurs
    • Children under 6 months: ask a doctor
  • DO NOT USE

    • Do not use on damaged or broken skin.
  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children
  • WARNINGS

    • For external use only.
    • Do not use on damaged or broken skin.
    • When using this product keep our of the eyes. Rinse with water to remove.
    • Stop use and ask a doctor if rash occurs.
    • Keep out of reach of children
    • Children under 6 months: as a doctor
  • QUESTIONS

    • + 34 913456902 M-F 9:00 am to 5:00 pm
  • INDICATIONS & USAGE

    • deodorizes, refreshes and avoids the consequences of the agressive actions of the detergents in the genital areas
  • DOSAGE & ADMINISTRATION

    • apply pulverizing over the genital zone keeping the container in an upright position
    • 3 or 4 applications per day used to be anough, but it can be used as often as necessary
  • PURPOSE

    • apply pulverizing over the genital zone keeping the container in an upright position
    • 3 or 4 applications per day used to be anough, but it can be used as often as necessary
  • INACTIVE INGREDIENT

    Propyleneglycol, water, Polysorbate 80, Glycyrrhizinic Acid, Sodium Benzoate, Potassium Sorbate, TEA

  • PRINCIPAL DISPLAY PANEL

    box

  • INGREDIENTS AND APPEARANCE
    GLIZIGEN SKIN PROTECTANT 
    glycerin spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64539-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 80 (UNII: 6OZP39ZG8H) 0.8 mg  in 1 mL
    SODIUM BENZOATE (UNII: OJ245FE5EU) 0.1 mg  in 1 mL
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.1 mg  in 1 mL
    WATER (UNII: 059QF0KO0R) 100 mg  in 1 mL
    PROPANEDIOL (UNII: 5965N8W85T) 50 mg  in 1 mL
    TEA LEAF (UNII: GH42T47V24) 0.1 mg  in 1 mL
    GLYCYRRHIZIN (UNII: 6FO62043WK) 0.1 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64539-004-0160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/07/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/07/2017
    Labeler - Catalysis, SL (862795119)
    Registrant - Catalysis, SL (862795119)
    Establishment
    NameAddressID/FEIBusiness Operations
    Catalysis, SL862795119manufacture(64539-004)
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